Introduction to Root Cause Investigation for CAPA 2019 is a webinar that covers topics such as:
- FDA and ISO (13485) Requirements
- What is CAPA vs Correction
- Steps in a CAPA Process
- CAPA’s Criticality in Quality Systems
- Risk Management as Part of CAPA
- Quality Data Sources for CAPA
- Challenges Associated to RCA
- What is a Root Cause Analysis (RCA)/Investigation
- Six Steps in Problem Solving
- Difference between a direct cause, a contributing cause and a true root cause
- Tools Used for RCA/Investigation
- Steps to Follow If the Root Cause is Not Clearly Known
- Examples of Three of These Tools and When to Use Them
Introduction to Root Cause Investigation for CAPA 2019 is intended for:
- Quality Assurance/ Quality Control Personnel
- CAPA Owners
- Document Control Personnel
- Regulatory Compliance Professionals
- Quality and Manufacturing Engineer
- Regulatory Affairs Professionals
- Quality Auditors
- Supplier Quality Managers